510(k) · Cleared
ClearedPowdered Natural and/or Colored Latex Exam Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Nov 8, 2002 as substantially equivalent to K943807 (Shield Gloves Manufacturer (M) Sdn Bhd, 1994) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Nov 8, 2002
- Review
- 14 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943807 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK943807 Royal Shield Pink Colored Non-Sterile Latex Examination GloveShield Gloves Manufacturer (M) Sdn Bhd · 1994
- This deviceK023590 Powdered Natural and/or Colored Latex Exam GlovesYty Industry (Manjung) Sdn Bhd · 2002
- Descendant · cites it directly · 0 of its ownK024355 Evergreen Non-Sterile Powdered Natural or Colored Latex Examination…Yty Industry (Manjung) Sdn Bhd · 2003
Most influential descendants
Showing 1 of 1 · See all- K024355Evergreen Non-Sterile Powdered Natural or Colored Latex Examination GloveYty Industry (Manjung) Sdn Bhd · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943807 | Royal Shield Pink Colored Non-Sterile Latex Examination Glove | Shield Gloves Manufacturer (M) Sdn Bhd | 1994 | — |
| 0 (this device) | K023590 | Powdered Natural and/or Colored Latex Exam Gloves | Yty Industry (Manjung) Sdn Bhd | 2002 | — |
| +1 | K024355 | Evergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove | Yty Industry (Manjung) Sdn Bhd | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYY device
- #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943807 | Royal Shield Pink Colored Non-Sterile Latex Examination GloveSummary page 1…ted by U.S. companies. It is Substantially Equivlalent to the devices manufactured by Shield Gloves Manufacturer (MJK943807, and YTY Industry (Manjung) SDN BHD, K974 191 (natural color). 7.0 Summary of P… | 1994 |
| * | K974191 | Evergreen Non-Sterile Powdered Latex Examination GloveSummary page 1…uivlalent to the devices manufactured by Shield Gloves Manufacturer (MJK943807, and YTY Industry (Manjung) SDN BHD, K974 191 (natural color). 7.0 Summary of Performance Data:… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024355 | Evergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 2025
MAUDE reports naming product code LYY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 75 | 0 | 11 |
| 2008 | 13 | 151 | 0 | 14 |
| 2009 | 7 | 76 | 0 | 11 |
| 2010 | 13 | 106 | 0 | 10 |
| 2011 | 11 | 127 | 1 | 4 |
| 2012 | 11 | 133 | 0 | 1 |
| 2013 | 6 | 131 | 0 | 2 |
| 2014 | 3 | 156 | 0 | 6 |
| 2015 | 3 | 251 | 0 | 5 |
| 2016 | 4 | 142 | 0 | 7 |
| 2017 | 4 | 230 | 0 | 7 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 8 | 188 | 0 | 1 |
| 2022 | 14 | 150 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023590: Powdered Natural and/or Colored Latex Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023590
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026